Early results were announced from a study evaluating the immune response of Arexvy (respiratory syncytial virus vaccine, adjuvanted) in adults 50 to 59 years of age.
Arexvy is currently approved for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 60 years of age and older.
The randomized, observer-blind, placebo-controlled study (ClinicalTrials.gov Identifier: NCT05590403) included approximately 1520 individuals aged 50 to 59 years. Of these participants, 570 were at increased risk of RSV-LRTD with predefined stable chronic diseases (eg, chronic pulmonary disease, chronic cardiovascular disease, diabetes, chronic kidney disease or chronic liver disease).
Findings showed that a single dose of Arexvy elicited a noninferior immune response (RSV-A and RSV-B neutralization titers) in adults 50 years of age and older at increased risk of RSV when compared with data observed in adults 60 years of age and older (primary endpoint). Noninferior immune responses were also observed in the broader group of adults 50 to 59 years of age. The most common adverse reactions reported were pain, fatigue, and headache, most of which were transient and mild in intensity.
“This trial reinforces our confidence in our RSV vaccine’s ability to help protect adults aged 50 to 59 at increased risk for RSV-LRTD, said Tony Wood, Chief Scientific Officer, GSK. “We will submit these data for regulatory review as quickly as possible with the goal of offering adults in this age group the option of a vaccine for the first time.”
This article originally appeared on MPR
References:
New data for Arexvy, GSK’s RSV vaccine, show potential to help protect adults aged 50 to 59 at increased risk for RSV disease. News release. GSK. October 25, 2023. www.businesswire.com/news/home/20231024909863/en/New-Data-for-AREXVY-GSK%E2%80%99s-RSV-Vaccine-Show-Potential-to-Help-Protect-Adults-Aged-50-to-59-at-Increased-Risk-for-RSV-Disease.
